Study of Safety and Efficacy of an Oral Contraceptive

Overview

This is a non-comparative study. the primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

Full Title of Study: “An Open Label Study of the Contraceptive Efficacy of Norethindrone and Ethinyl Estradiol.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2009

Interventions

  • Drug: Norethindrone/ethinyl estradiol
    • 1 tablet per day

Arms, Groups and Cohorts

  • Experimental: Norethindrone/ethinyl estradiol
    • 1 tablet per day

Clinical Trial Outcome Measures

Primary Measures

  • Pearl Index, 18-35 Years, MITT Population
    • Time Frame: 13 cycles (28 days each), approximately 364 days
    • Pregnancy rate in women 18-35 years old, Pearl Index – number of pregnancies per 100 women-years of treatment

Secondary Measures

  • Mean Number of Days of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
    • Time Frame: 12 cycles (28 days each), approximately 336 days
  • Mean Median Duration (Days) of Intracyclic Bleeding & Spotting, Cycles 2-13, MITT Population
    • Time Frame: 12 cycles (28 days each), approximately 336 days
    • Each IB episode has a unique duration, with 0, 1, 2, 3 or more episodes per cycle. To obtain “mean median duration” of episodes during a cycle, take the median duration of all episodes in each cycle. If there are no episodes in the cycle, then median duration is undefined/missing for that cycle. 1 episode – median duration = duration of that episode, 2 episodes – median duration = average of 2 durations, more than 2 episodes, calculated in usual way for median of an ordered set of numbers. Once median determined for each cycle/subject, the mean & SD of those quantities calculated.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy Women – Age 18-45 – At risk for pregnancy – History of regular cycles Exclusion Criteria:

  • Contraindications for use of hormonal contraception – Conditions which affect the absorption or metabolism of steroid hormones – BMI>35

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Warner Chilcott
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Herman Ellman, Study Director, Sponsor GmbH

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